NCT03726346

The Evaluation of the Toffee Mask for the Treatment of Obstructive Sleep Apnea

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Fisher and Paykel Healthcare · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

This investigation is a prospective, non-randomized, non-blinded study. This investigation is designed to evaluate the performance, comfort and ease of use of the F\&P Toffee mask amongst Obstructive Sleep Apnea (OSA) patients. Up to 45 OSA patients will be recruited from the Pulmonary Disease Specialists Research database.

Detailed description

Visit 1 will involve the participants being consented into the trial. Visit 2 will involve the participants being fitted with the F\&P Toffee mask for use in home. The participant will then come in to return the mask (Visit Three) and have a final interview, this ensures the maximum time participants will be exposed to the Toffee mask in home will be 14 ± 4 days from visit two. The mask will be returned to the Institution at the conclusion of the trial and the participant will return to their previous mask. The Institution will recruit all patients within 2 weeks of the beginning of the study.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	Toffee Full Face Mask	Participants will be placed on this arm for a total of 14+- 4 days from visit 2. Participants will be using the Toffee mask during this treatment arm.

Timeline

• Start date: 2018-11-26
• Primary completion: 2018-12-13
• Completion: 2019-11-13
• First posted: 2018-10-31
• Last updated: 2022-06-21
• Results posted: 2022-06-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study